Effects of Endurance Training on Patients With Reduced Le... | NCT00472238

Studies
Effects of Endurance Training on Patients With Reduced Left Ventricular Ejection Fraction (LVEF) and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias

NCT00472238

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Nov 20, 2008Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Heart Failure
Cardiac Resynchronisation Therapy
Sudden Cardiac Death

Interventions

endurance training
exercise training

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
001

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

May 10, 2007

First Submission Date that Met QC Criteria

May 10, 2007

First Posted Date

May 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2008

Last Update Posted Date

Nov 20, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A severely reduced left ventricular ejection fraction is associated with increased mortality due to pump failure as well as to malignant ventricular arrhythmia. We hypothesize that targeted training may lead to improved survival and to increased parameters of risk stratification for malignant arrhythmia. Additionally, the training may lead to an improved psychological and mental condition of the patients

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1, Training	Experimental	Group for training therapy	Behavioral: exercise training
2, Control	Active Comparator		Behavioral: endurance training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endurance training	Behavioral	control group.	2, Control
exercise training

Measure	Description	Time Frame
left ventricular function		3 months
aerobic threshold		3 months

Measure	Description	Time Frame
quality of life		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CRT Device

Exclusion Criteria:

refused informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dirk Müller, MD, PhD	Charite University, Berlin, Germany	Principal Investigator
Fernando C Dimeo, MD, PhD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité campus Benjamin Franklin	Recruiting	Berlin	State of Berlin	12200	Germany

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D016757	Death, Sudden, Cardiac

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D006323	Heart Arrest
D003645	Death, Sudden
D003643	Death
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000076663	Endurance Training
D015444	Exercise

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics
D026741	Physical Therapy Modalities
D064797	Physical Conditioning, Human
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena